Back in 2007 John Gosnell & Co. Limited and its sister company Courtin & Warner Limited knew only too well that, as manufacturers of Pharmaceutical and Food products, they needed a best in class Enterprise Resource Planning (ERP) system to support their key quality assurance and traceability processes. The system needed to manage their entire supply chain process whilst, at the same time ensuring that they met their industries regulatory and best practice guidelines. Both companies needed to improve their operating efficiencies to maintain cost-controlled operations and they required a tightly integrated supply chain execution system that held accurate, real-time data right from receipt of raw materials through to delivery of the finished product to their customers.
John Gosnell and Courtin & Warner have a wealth of experience in the supply, manufacture and packaging of cosmetics, pharmaceutical and foodstuff products. With customers including major household names, as well as a number of NHS Pharmaceutical Manufacturing Units (PMUs), quality assured processing and traceability are vital ingredients to both companies’ supply chain processes.
The key selection criteria for the choice of system were decided. The chosen system would need to be fully functional, robust and secure – for Courtin and Warner, the pharmaceutical manufacturing business, it needed to support the pharmaceutical industries standards for Good Automated Manufacturing Process (GAMP). It also needed to be sufficiently flexible to enable the company to continue to offer its customers effective and imaginative solutions for a wide range of products, processes, repacking and handling solutions.
The WinMan system was chosen because it met all of the selection criteria. It also had the flexibility to handle the cosmetics manufacturing requirements, for the initial implementation at John Gosnell, and the additional requirements needed for the pharmaceuticals and foodstuffs manufacture at Courtin and Warner. As an ERP system designed specifically for manufacturers and distributors, the WinMan system met the GAMP compliance requirements set by the companies’ two main regulatory bodies; BRC and MHRA. The most recent audit by MHRA validated Courtin and Warner’s manufacturing process, their GAMP status was confirmed, and the company received a three year compliance certification.
The most critical requirement for an ERP system operating in an MHRA regulated environment is ‘cradle to grave and grave to cradle’ lot traceability. In order to submit this kind of information to the MHRA the system must be validated. Validation of the WinMan system is an integral part of the implementation process. The WinMan implementation consultants prepare test scripts with the users for each of the key processes such as lot traceability, system security, product structure maintenance, manufacturing data capture, engineering change control, invoicing, and shipment. The test scripts are then used to validate that the system performs as expected, train users in the operation of the system and also to identify any areas where system configurations may need to be made.
In addition to the companies regulatory bodies audit, the company’s own customers, both commercial and NHS, make regular stringent audit visits to validate processes and systems. The primary reason for this is to ensure that their manufacturing and supply chain systems operate to the customers own high standards, and conform to best practice in all supply chain processes.
The WinMan system fully supports John Gosnell and Courtin and Warner’s quality assurance processes. There are key areas of the system that integrate with the companies quality assurance processes.
Matt Fry, Technical Manager for both companies, is responsible for quality assurance. Matt takes up the story: “The WinMan security system makes sure that only authorised and qualified members of our staff have access to key areas of the WinMan system. For example only qualified members of staff in the technical and QA departments can setup and maintain formulations, recipes and product tests. The WinMan system’s ECN (Electronic Change Notice) process ensures that only approved versions of product structures are available to be used within the manufacturing process.”
Matt further explains: “We use the WinMan Test functionality extensively to manage our raw material and finished product QA testing and approvals process. Typically, tests will be set up to record spectrometer analysis, make sure that products have the correct CoC (Certificates of Conformity) and that batch numbers and expiry dates are valid. The WinMan system only allows batches of raw materials that have passed the appropriate tests to be released into the manufacturing process. In addition, we perform organoleptic tests on our finished products for appearance, colour and odour.”
A product recall is the ultimate test of an ERP systems traceability functionality and its ability to transfer and maintain accurate lot data throughout supply chain operations. Both John Gosnell and Courtin & Warner need to be able to take action within hours of a product recall. Rapid retrieval of traceability records are the key to helping the companies meet regulatory guidelines and prevent any harm. The WinMan system’s ability to narrow down the scope of the recall to just those finished products that were made from the specific lot that is in question, is critical to identifying exactly which finished products are at issue. Organisations don’t want to incur the cost of recalling all shipments if it can pinpoint only a few products that could be problematic. Courtin & Warner perform bi-annual mock recalls to validate the product recall process and this has shown that the WinMan system dramatically reduces product identification times.
The WinMan system manages expiry dates, and both John Gosnell and Courtin & Warner record lot numbers and expiry dates against receipts of raw materials. The WinMan inventory management and material requirements planning functions ensures that the raw materials with the shortest expiry date are consumed first and that stock levels are maintained at their minimum level.
Matt continues: “With product expiry dates becoming shorter and shorter being able to rotate stock automatically and maintain inventory levels at a lean level is vital. Working in a lean manner has both quality and financial benefits – the risk of using out-of-date raw materials in finished products is minimised and the cost of wastage is reduced.”
Matt comments on the future: “We will be moving to a new, purpose built facility next year and one of our objectives is to operate in a paperless environment. We are considering using WinMan touch screen Kiosk terminals to lead our production staff through the manufacturing process and capture manufacturing data.
“The Kiosk operation would replace the paper based work sheets currently used and be essential within a sterile production environment. Using Kiosk terminals to update work in progress will give the companies’ more accurate production costs and also visibility of work-in-progress which would improve both production scheduling and customer service.”
Matt concludes: “In the short term we are looking to utilise WinMan’s integrated document management facility. Initially this will be used to automate the emailing of CoCs (Certificates of Conformity) to our customers prior to despatch. When we move to paperless operation we would also make SOPs (Standard Operating Procedures) available to our production team in an electronic form on the Kiosk terminal at the point and time of manufacture.”